N4 Pharma Plc (AIM: N4P), the specialist pharmaceutical company which improves the delivery of existing drugs and novel vaccines and therapeutics, is pleased to announce the start of its proof of concept clinical trial for its lead product, sildenafil, (the “Trial”) following the completion of the validation of the reformulated sildenafil in accordance with the specifications submitted to the MHRA.
The Trial will comprise a four way crossover study in 12 healthy subjects comparing N4 Pharma’s reformulated 100mg sildenafil to Viagra™ 50mg in both fed and fasted conditions. The Trial aims to measure the level of the drug in plasma achieved by N4 Pharma’s reformulated product compared to Viagra™ over a 24 hour period.
The Trial is expected to take 8 to 10 weeks with provisional results data available in July 2018 with the final clinical study report expected at the end of August 2018.
The data gathered from the Trial will enable the Company to establish whether its reformulation has been sufficiently successful to allow N4 Pharma to prepare for a pre-IND meeting with the FDA towards the end of this year or whether further amendments to the reformulation may be required to optimise efficacy.
Nigel Theobald, CEO of N4 Pharma, commented: “We are delighted that N4 Pharma’s first clinical trial has begun on our lead product, sildenafil. Slight delays in receiving the base ingredients to the reformulation, which had a knock effect on the validation of the product, has seen the timetable slip slightly. However, there should be no material impact on any move towards commercialisation assuming successful Trial results.
“The Board continues to believe that the improvements sought to be evidenced through the Trial will make our reformulation that much more attractive to both the end consumer and pharmaceutical partners in the final development and commercialisation of the drug in this highly lucrative market.
“We look forward to providing a further update as soon as we receive the full results which are expected in late August.”